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HAYWARD, Calif.--(BUSINESS WIRE)--Nov 2, 2022--
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today reported financial results for the third quarter ended September 30, 2022 and provided a pipeline update on its six clinical-stage molecules – targeting TIGIT, the adenosine axis (CD73 and A2a/A2b), HIF-2a and PD-1 – across multiple common cancers. As part of its pipeline update, the company is announcing a strategic protocol amendment to the ARC-10 registrational Phase 3 study following proactive discussions with the U.S. Food and Drug Administration (FDA). The new, amended ARC-10 study design will compare domvanalimab and zimberelimab to pembrolizumab, a global standard-of-care (SOC) in PD-L1-high NSCLC, the target indication for ARC-10; the study will no longer include a chemotherapy arm.
“Arcus continues to execute on its strategy to be a leader in the TIGIT field and to advance our clinical pipeline, including our adenosine pathway modulators etrumadenant and quemliclustat,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “The optimization of our Phase 3 ARC-10 study design and the initiation of the fourth Phase 3 registrational study for domvanalimab position Arcus to leverage the full potential of domvanalimab. We continue to have strong conviction that domvanalimab plus zimberelimab has the potential to be a best-in-class anti-TIGIT / anti-PD-(L)1 regimen and to create a new standard-of-care in multiple settings. With $1.2 billion and a deep pipeline of six, soon to be eight, clinical-stage molecules, we are poised to be a leader in the development of innovative therapies for cancer patients in need.”
ARC-10 Strategic Amendment
ARC-10 is a randomized Phase 3 study evaluating the efficacy of domvanalimab plus zimberelimab in 1L PD-L1≥50% locally advanced or metastatic NSCLC.
The strategic amendment revises the design to compare the combination of domvanalimab plus zimberelimab to SOC pembrolizumab, enabling an expanded geographic footprint for the trial. In addition, this amendment addresses the importance, both clinically and commercially, of using an accepted U.S. SOC as an active comparator for the trial, in the context of a potentially shifting U.S. regulatory landscape for oncology agents. The re-design of the ARC-10 study complements the ongoing STAR-121 study, comparing domvanalimab plus zimberelimab and chemotherapy versus SOC pembrolizumab plus chemotherapy, in 1L PD-L1 all-comer NSCLC. Together with the PACIFIC-8 study in Stage III NSCLC, these three registrational Phase 3 trials will establish the potential benefit of domvanalimab in a broad spectrum of NSCLC settings.
The key components of the protocol amendment for ARC-10, following proactive discussions with the FDA, are as follows:
Additional Pipeline Highlights:
Domvanalimab (Fc-silent anti-TIGIT monoclonal antibody)
Domvanalimab Updates:
Upcoming Domvanalimab Milestones:
Etrumadenant (A2a/A2b adenosine receptor antagonist)
Upcoming Etrumadenant Milestones:
Quemliclustat (small-molecule CD73 inhibitor)
Upcoming Quemliclustat Milestones:
AB521(HIF-2ainhibitor)
AB521 Update:
Discovery Programs:
Financial Results for the Third Quarter 2022
Arcus Ongoing and Announced Clinical Studies
Trial Name
Arms
Setting
Status
NCT No.
Lung Cancer
ARC-7
zim vs. dom + zim vs. etruma + dom + zim
1L NSCLC (PD-L1 ≥ 50%)
Ongoing Randomized Phase 2
PACIFIC-8
(AZ)
dom + durva vs. durva
Curative-Intent Stage 3 NSCLC
Ongoing Registrational Phase 3
ARC-10
dom + zim vs. pembro
1L NSCLC (PD-L1 ≥ 50%)
Ongoing Registrational Phase 3
STAR-121
(GILD)
dom + zim + chemo vs pembro + chemo
1L NSCLC (PD-L1 all-comers)
Ongoing Registrational Phase 3
EDGE-Lung
dom +/- zim +/- quemli +/- chemo
1L/2L NSCLC (lung cancer platform study)
Initiating Phase 2
TBD
Velocity-Lung
(GILD)
dom +/- zim +/- etruma +/- sacituzumab govitecan (Trodelvy®) or other combos
1L/2L NSCLC (lung cancer platform study)
Initiating Phase 2
TBD
Gastrointestinal Cancers
ARC-9
etruma + zim + mFOLFOX vs. SOC
2L/3L/3L+ CRC
Ongoing
Randomized Phase 2
ARC-21
dom + zim ± chemo
1L/2L Upper GI Malignancies
Ongoing
Phase 2
STAR-221
dom + zim + chemo vs. nivo + chemo
1L Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinoma (EAC)
Planned Registrational Phase 3
Pancreatic Cancer
ARC-8
quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac
1L, 2L PDAC
Ongoing Randomized Phase 1/1b
Prostate Cancer
ARC-6
etruma + zim + SOC vs. SOC (Adding sacituzumab govitecan (Trodelvy) combination cohorts)
2L/3L CRPC
Ongoing Randomized Phase 2
Various
ARC-12
AB308 + zim
Advanced Malignancies
Ongoing
Phase 1/1b
ARC-14
AB521
Healthy Volunteers
Ongoing
ARC-20
AB521
Cancer Patients / ccRCC
Planned Phase 1/1b
dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; nivo: nivolumab; pembro: pembrolizumab; quemli: quemliclustat; SOC: standard-of-care; zim: zimberelimab
ccRCC: clear-cell renal cell carcinoma; CRC: colorectal cancer; CRPC: castrate-resistant prostate cancer; GI: gastrointestinal; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma
About the Gilead Collaboration
In May 2020, Gilead and Arcus entered into a 10-year collaboration that provided Gilead immediate rights to zimberelimab and the right to opt into all other Arcus programs arising during the collaboration term. In November 2021, Gilead and Arcus amended the collaboration in connection with Gilead’s option exercise for three of Arcus’s then-clinical stage programs. For all other programs that are in clinical development or new programs that enter clinical development thereafter, the opt-in payments are $150 million per program. Gilead’s option, on a program-by-program basis, expires after a specified period of time following the achievement of a development milestone for such program and Arcus’s delivery to Gilead of the requisite qualifying data package. Concurrent with the May 2020 collaboration agreement, Gilead and Arcus entered into a stock purchase agreement under which Gilead made a $200 million equity investment in Arcus. That stock purchase agreement was amended and restated in February 2021 in connection with Gilead’s increased equity stake in Arcus from 13% to 19.5%, with an additional $220 million investment.
Gilead and Arcus are co-developing and equally share global development costs for five clinical candidates, including domvanalimab, an Fc-silent anti-TIGIT antibody, etrumadenant, a dual adenosine A2a/A2b receptor antagonist, quemliclustat, a small molecule inhibitor of CD73, and zimberelimab, an anti-PD1 antibody.
About Arcus Biosciences
Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry partners, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of six investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis (CD73 and dual A2a/A2b receptor) and HIF-2a. For more information about Arcus Biosciences’ clinical and pre-clinical programs, please visit www.arcusbio.com or follow us on Twitter.
Forward-Looking Statements
This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein, including, but not limited to, the statements in Dr. Rosen’s quote, Arcus’s expectation that its cash, cash equivalents and marketable securities on-hand are sufficient to fund operations into 2026, future data disclosures and presentations, the projected achievement of clinical study milestones and their associated timing (including under the captions “Upcoming Domvanalimab Milestones,” “Upcoming Etrumadenant Milestones,” “Upcoming Quemliclustat Milestones,” and “Discovery Programs”), and additional clinical studies in planning or expected to be initiated are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: risks associated with preliminary and interim data not being guarantees that future data will be similar; the unexpected emergence of adverse events or other undesirable side effects; difficulties or delays in initiating or conducting clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials, all of which may be exacerbated by the COVID-19 pandemic; Arcus’s dependence on the collaboration with Gilead for the successful development and commercialization of its optioned molecules; difficulties associated with the management of the collaboration activities or expanded clinical programs; changes in the competitive landscape for Arcus’s programs; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, filed on November 2, 2022 with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release except to the extent required by law.
The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.
ARCUS BIOSCIENCES, INC.
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(In thousands, except share and per share amounts)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2022
2021
2022
2021
Revenues:
License and development service revenue
$
23,742
$
-
$
48,374
$
-
Other collaboration revenue
9,839
9,461
29,971
28,383
Total revenues
33,581
9,461
78,345
28,383
Operating expenses:
Research and development
76,684
71,254
207,800
206,412
General and administrative
26,294
16,343
76,104
48,990
Total operating expenses
102,978
87,597
283,904
255,402
Loss from operations
(69,397
)
(78,136
)
(205,559
)
(227,019
)
Non-operating income (expense):
Interest and other income, net
5,013
161
8,456
481
Effective interest on liability for sale of future royalties
(535
)
-
(1,437
)
-
Total non-operating income, net
4,478
161
7,019
481
Net loss before income taxes
(64,919
)
(77,975
)
(198,540
)
(226,538
)
Income tax expense
-
-
(1,004
)
-
Net loss
(64,919
)
(77,975
)
(199,544
)
(226,538
)
Other comprehensive loss
(2,557
)
(46
)
(8,540
)
(136
)
Comprehensive loss
$
(67,476
)
$
(78,021
)
$
(208,084
)
$
(226,674
)
Net loss per share, basic and diluted
$
(0.90
)
$
(1.11
)
$
(2.78
)
$
(3.28
)
Weighted-average number of shares used to compute basic and diluted net loss per share
72,236,283
70,110,138
71,752,246
68,990,290
Selected Consolidated Balance Sheet Data
(unaudited)
(In thousands)
September 30,
2022
December 31,
2021 (1)
Cash, cash equivalents and marketable securities
$
1,191,920
$
681,298
Total assets
1,393,822
1,591,898
Total liabilities
695,121
750,448
Total stockholders’ equity
698,701
841,450
(1)
Derived from the audited financial statements for the year ended December 31, 2021, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 23, 2022.
View source version on businesswire.com:https://www.businesswire.com/news/home/20221102005351/en/
CONTACT: Investor Inquiries:
Pia Banerjee
Head of Investor Relations & Strategy
(617) 459-2006
pbanerjee@arcusbio.comMedia Inquiries:
Holli Kolkey
VP of Corporate Communications
(650) 922-1269
hkolkey@arcusbio.com
KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA
INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH CLINICAL TRIALS
SOURCE: Arcus Biosciences
Copyright Business Wire 2022.
PUB: 11/02/2022 04:02 PM/DISC: 11/02/2022 04:02 PM
http://www.businesswire.com/news/home/20221102005351/en